Technical Guidelines on the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices Issued

Chinese version
The China Food and Drug Administration ("CFDA") has recently issued Technical Guidelines on the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices (the "Technical Guidelines").

The Technical Guidelines apply to the guidance on the acceptance of the applicant's proposed use of data sourced from overseas clinical trials for a medical device (including IVD reagents) as the materials for clinical assessment, when he applies for registering the medical device in China. The Technical Guidelines set forth basic rules on accepting the overseas clinical trial data, and make clear the required documents concerning the overseas clinical trial data and the technical requirements on such data. According to the Guidelines, the documentation submitted by an applicant regarding the clinical trials performed overseas shall include the scheme for clinical trials, ethical comments, and the report for clinical trials, at least. The report for clinical trials shall include an analysis of all data collected from clinical trials and a conclusion drawn herein. Furthermore, the Technical Guidelines expound on which factors shall be taken into account, as well as the technical requirements in this regard, before overseas clinical trial data are accepted, from the perspective of differences in the technical evaluation requirements, research subjects and conditions for clinical studies, and cite several specific examples where certain factors have an impact for the clinical trial purpose on the clinical data.